Obligatory quality management and accreditation in laboratory medicine
Hôpital, Patients, Santé et Territories (HPST), a new hospital reform bill, was passed by the French Government and became law in July 2009. While directly related to hospitals it also places new importance on health from the patients’ perspective outside the hospital. Importantly for laboratory medicine, the act makes accreditation for both public and private laboratories obligatory rather than mandatory.
According to article 69 of the HPST law, within six months from its publication all laboratories must put in process the steps that will control the creation, organisation and running of medical biology labs. In practice, this aims to guarantee better the quality of tests provided by laboratories.
For Jean Benoît, President of the Syndicat des Biologistes (French biologists union), making accreditation obligatory is an important step in the quality process. Accreditation is the best way to follow the quality of services offered by laboratories and to ensure that results are standardised across the country.
In line with European law, accreditation will at first only be granted at national level by an organisation known as Cofrac, which has been given the task of inspecting laboratories and giving certificates where gained. Due to the importance of this sector, Cofrac is creating a new department, ‘Human Health’, to cope with the task ahead. (Details: www.cofrac.fr).
Once granted, accreditation covers all activities carried out by the lab, but it will have to be renewed frequently, probably every 15-18 months. The accreditation that may cover numerous labs from different sites and many different procedures has to be continuous, from the taking of samples to the presentation and interpretation of results.
Amongst health professionals in France, medical biologists are the only ones to have already put in place practice guidelines that include quality assurance. Their good laboratory practice guide, GBEA dates back to 1994 and Bio Qualité was introduced in 2002. This latter was an initiative driven by the profession, which guided LAMs, (medical analysis labs) to put all the necessary quality assurance steps in place. Bio Qualité corresponds closely to standards ISO 9001 (95%) and EN 15189 (85%). The EN 15189 is the accreditation standard chosen by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for all European medical laboratories.
Almost 3,000 labs in France are members of Bio Qualité, which is ISO 9001, recognised by the national health authority (HAS) and the social security (CPAM).
According to Cofrac only 100 out of a total of more than 5,000, are so far accredited EN 15189, so there is a formidable job in front of French laboratories and accrediting staff, which will be essential in promoting the quality of the work carried out in biological laboratories in this country.
Report: Jane MacDougall
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